With so much of MedTech resembling a medical device, and with more medical devices incorporating software and other digital components, it is ever harder to define what is a MedTech and what is a medical device localization project. With the possibility some projects encompass both, companies working in this sensitive and highly regulated space need the assurance that their products, interfaces, and documentation translations are viable in global regulatory environments, which starts and ends with having a multilingual communications partner adept in the most important quality management stipulation surrounding medical devices: namely, ISO standard 13485:2016.
In today’s global marketplace, the localization of medical products into what is often upwards of 10 languages is a crucial element of achieving market entry and success in practice. Whether it’s a digital platform for medical technology or a physical medical device, the localized product needs to provide the necessary linguistic and cultural adaptation to meet the needs of diverse stakeholders in its target market. Thus, while MedTech localization and medical device localization share many similarities, their significant differences make it important to work with a localization partner with proven credentials and a strong knowledge of their interrelationship. In particular, working with an ISO 13485:2016 certified language service provider (LSP) like CSOFT Health Sciences can help clients achieve successful localization for both types of products.
Similarities and Differences in MedTech and Medical Device Localization
Broadly, MedTech localization involves adapting software or digital platforms used in medical technologies to meet the linguistic, cultural, and regulatory requirements of different target markets. This can include translation and localization of user interfaces, help files, documentation, and marketing materials. However, a comprehensive localization strategy may also extend to training and educational material, among other features. MedTech localization further involves adapting software or digital platforms to comply with any distinct local regulations, such as data privacy laws or medical device regulations. The process of MedTech localization thus requires a deep understanding of both the technology it is built on and the local culture and regulatory requirements of end users.
By contrast, medical device localization primarily involves adapting physical products to meet the regulatory and cultural requirements of different markets. This can include translation and localization of labeling, packaging, and instructions for use, in terms of the most common needs. Medical device localization may also involve adapting product design to meet regulatory and cultural requirements, such as changing the dimensions or materials of a device to comply with local regulations or the preferences of the target market, and may even require the documentation of MedTech components as detailed above. Like MedTech, and to a still greater degree under policies such as the EU-MDR, medical device localization requires in-depth knowledge of regulatory compliance, cultural norms, and technical specifications.
By working with an ISO 13485:2016 certified LSP, clients can benefit from a reliable and effective localization process in either scenario. With medical devices pre-standing much of MedTech, the ISO 13485:2016 international standard informs and reflects an existing regulatory landscape that many MedTech products interact with by way of medical devices or their prevalence in medical practices they likewise aim to assist. An LSP that is certified to this standard demonstrates its commitment to quality, regulatory compliance, and continuous improvement in service of its clients’ needs. With CSOFT, companies can thus ensure that the localization process they entrust to our network of in-country linguists complies with the foremost quality management system specific to the medical device industry.
More About CSOFT’s MedTech and Medical Device Localization Services
As an early adopter of ISO 13485:2016 for key regional operations, and with our worldwide operations certified in the standard on a global basis, CSOFT is well equipped in the foundations of medical device quality management, as well the art and science of delivering technology-driven translation solutions. Our history as a multidecade provider of custom multilingual communication solutions includes a full range of software, document, website, and physical product localization services that we offer in 250+ languages. To learn more or to get in contact with a member of our team, visit lifesciences.csoftintl.com.